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LB85

by Steris Corporation

Ref LB85Model Sterile Camera Cover

LB85 is a device classified as Class I in the EU and Class II in the US made by Steris Corporation, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 0724995MGSTERILCAMCVRKW) and listed in FDA GUDID since 17 Nov 2023 (UDI-DI 00724995203399), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995MGSTERILCAMCVRKW Basic UDI-DI 00724995203399UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995203399 UDI-DI Date17 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0724995MGSTERILCAMCVRKW registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI 00724995203399 listed 17 Nov 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00724995203399
  2. Registered EUDAMED 0724995MGSTERILCAMCVRKW

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Medical equipment handle cover, single-use
Device name
Sterile Camera Cover
Model / Ref / Catalog
LB85, Sterile Camera Cover
Primary DI / UDI-DI
00724995203399
Basic UDI-DI
0724995MGSTERILCAMCVRKW
FDA product code
FTA
EMDN code
Z12010785 Scialytic lamp lighting systems - consumables
GMDN term
Medical equipment handle cover, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4580
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Medical equipment handle cover, single-use

Similar devices in this category

Other devices filed under SCIALYTIC LAMP LIGHTING SYSTEMS.

Other devices from Steris Corporation

See all devices from Steris Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)